Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD

NCT02561520 | Withdrawn Phase 1 DMC

• 1 other identifier: PRO15070211
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of ocular graft versus host disease (O-GVHD). In addition to their current medication (except autologous serum drops), patients will receive PRP and PPP drops.

Conditions

Graft-versus-host Disease

Keywords

platelet rich plasma; platelet poor plasma; ocular GVHD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  Safety and tolerability of topical autologous PRP and PPP four times a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the autologous blood products. The severity of each adverse event and relation to the study medication will be graded possibly, probably, or definitely related. Tolerability measures will be graded from trace to severe using a direct query method at each visit.

  8 Weeks

Secondary Outcomes (7)

• Efficacy of topical autologous PRP and PPP as measured by the National Eye Institute (NEI) grading scale

  8 weeks

• Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT)

  8 weeks

• Efficacy of topical autologous PRP and PPP as measured by Schirmer Test I

  8 weeks

• Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using real-time polymerase chain reaction (RT-PCR)

  8 weeks

• Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using flow cytometry (FC)

  8 weeks

Study Arms (1)

PRP and PPP

EXPERIMENTAL

PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.

Biological: PRP eye drops; Biological: PPP eye drops

Interventions

PRP eye drops BIOLOGICAL

Eye drops 4x a day, patients will start this eye drop first.

Also known as: Platelet rich plasma

PRP and PPP

PPP eye drops BIOLOGICAL

Eye drops 4x a day, patients will start this eye drops after PRP.

Also known as: Platelet poor plasma

PRP and PPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Willing and able to provide written informed consent.
• Willing and able to comply with study assessments for the full duration of the study.
• Diagnosis of ocular GVHD.
• Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
• In good stable overall health.

You may not qualify if:

• Remission from primary cancer in more than 5 years.
• History of thrombocytopenia (platelet\<50,000) in the last 2 weeks before study entry.
• Ocular or periocular malignancy.
• Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
• Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
• Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
• Current use of topical steroids more than twice a day.
• Change in frequency of topical cyclosporine and/or topical kineret within the last month.
• Signs of current infection, including fever and current treatment with antibiotics.
• Intra-ocular surgery or ocular laser surgery within the last 3 months.
• Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
• Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.

Sponsors & Collaborators

• Ladan Espandar: lead

Study Sites (1)

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Ladan Espandar, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisant Professor

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 28, 2015
• Study Start: December 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

US (1)